Cleared Special

K140060 - DIGITAL DENTAL INTRA ORAL SENSOR

K140060 is the FDA 510(k) clearance for DIGITAL DENTAL INTRA ORAL SENSOR by Rayence Co., Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 123-day FDA review.

K140060 · Rayence Co., Ltd. · Radiology device
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May 2014
Decision
123d
Days
Class 2
Risk

K140060 is an FDA 510(k) clearance for the DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Houston, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rayence Co., Ltd. devices

Submission Details

510(k) Number K140060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2014
Decision Date May 13, 2014
Days to Decision 123 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K140060.
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
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XGEO GR40CW
K140235 · Samsung Electronics Co., Ltd. · May 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056 · Rayence Co., Ltd. · May 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646 · Rayence Co., Ltd. · Apr 2014
BONE SUPPRESSION SOFTWARE
K133442 · Carestream Health, Inc. · Mar 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409 · Rayence Co., Ltd. · Feb 2014